A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines

Summary

This study will test the immune system response to and safety of two HIV vaccines alone and in combination: ALVAC-HIV (vCP1452) and LIPO-5. ALVAC-HIV (vCP1452) uses a canarypox virus with man-made parts of HIV attached to it. The canarypox virus cannot cause disease in people. LIPO-5 is a mixture of five man-made proteins similar to proteins found in HIV. These vaccines are not produced from live HIV or from infected cells and do not contain the virus. It is not possible to become infected with HIV from these vaccines.

Timeline

Start

2004-03

Primary completion

—

Completion

2007-03

Publications

• Background Evans TG, Keefer MC, Weinhold KJ, Wolff M, Montefiori D, Gorse GJ, Graham BS, McElrath MJ, Clements-Mann ML, Mulligan MJ, Fast P, Walker MC, Excler JL, Duliege AM, Tartaglia J. A canarypox vaccine expressing multiple human immunodeficiency virus type 1 genes given alone or with rgp120 elicits broad and durable CD8+ cytotoxic T lymphocyte responses in seronegative volunteers. J Infect Dis. 1999 Aug;180(2):290-8. doi: 10.1086/314895.
• Background Klinguer C, David D, Kouach M, Wieruszeski JM, Tartar A, Marzin D, Levy JP, Gras-Masse H. Characterization of a multi-lipopeptides mixture used as an HIV-1 vaccine candidate. Vaccine. 1999 Sep;18(3-4):259-67. doi: 10.1016/s0264-410x(99)00196-6.
• Background Pialoux G, Gahery-Segard H, Sermet S, Poncelet H, Fournier S, Gerard L, Tartar A, Gras-Masse H, Levy JP, Guillet JG; ANRS VAC 04 Study Team. Lipopeptides induce cell-mediated anti-HIV immune responses in seronegative volunteers. AIDS. 2001 Jul 6;15(10):1239-49. doi: 10.1097/00002030-200107060-00005.
• Background Gahery-Segard H, Pialoux G, Figueiredo S, Igea C, Surenaud M, Gaston J, Gras-Masse H, Levy JP, Guillet JG. Long-term specific immune responses induced in humans by a human immunodeficiency virus type 1 lipopeptide vaccine: characterization of CD8+-T-cell epitopes recognized. J Virol. 2003 Oct;77(20):11220-31. doi: 10.1128/jvi.77.20.11220-11231.2003.
• Frey SE, Peiperl L, McElrath MJ, Kalams S, Goepfert PA, Keefer MC, Baden LR, Lally MA, Mayer K, Blattner WA, Harro CD, Hammer SM, Gorse GJ, Hural J, Tomaras GD, Levy Y, Gilbert P, deCamp A, Russell ND, Elizaga M, Allen M, Corey L. Phase I/II randomized trial of safety and immunogenicity of LIPO-5 alone, ALVAC-HIV (vCP1452) alone, and ALVAC-HIV (vCP1452) prime/LIPO-5 boost in healthy, HIV-1-uninfected adult participants. Clin Vaccine Immunol. 2014 Nov;21(11):1589-99. doi: 10.1128/CVI.00450-14. Epub 2014 Sep 24.

Drugs

Indications